Z-1243-2011

Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories. These...

Name: Z-1243-2011 Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories. These...
Creator: Stryker Instruments Division of Stryker Corporation
Published: 2010-11-30
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2010-11-30 / Terminated / root cause: packaging

FDA source

Stryker Instruments Division of Stryker Corporation began a recall of Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories. These burs are intended for use during various surgical... on 2010-11-30. The reason FDA records is "Product was packaged with an incorrect packaging material and therefore has a potential to be non-sterile which, if contaminated, could lead to a patient infection". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1243-2011
Status: Terminated
Initiated: 2010-11-30
Posted: 2011-02-14
Terminated: 2011-04-13
Recalling firm: Stryker Corp.
Product: Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories. These burs are intended for use during various surgical procedures to cut hard tissue or bone and soft tissue. More specifically these burs are used for shaping the bone (femur) during orthopedic surgeries.
Product code: HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Reason for recall: Product was packaged with an incorrect packaging material and therefore has a potential to be non-sterile which, if contaminated, could lead to a patient infection.
Root cause tag: packaging
FDA root cause: Packaging
Action: The firm, Stryker, sent a "MEDICAL DEVICE RECALL NOTIFICATION" letter dated December 2, 2010 to all customers. The letter described the product, problem and the action to be taken by the customers. The customer were asked to complete and fax in the business reply form indicating they have received the notification and to indicate whether or not they have affected product on hand, and send back any affected product to Regulatory Affairs at Stryker Instruments. Stryker will then send a replacement product to the customer. Upon receipt of the completed business reply form, the customer will be contacted to arrange return of any affected product they have in their inventory. Once the affected product is received, a replacement 5190 TPS Series Bur will be sent to the customer. For questions regarding this recall, please contact Stryker Instruments at 1-800-800-4236 ext. 3584 or [email protected].
Distribution: Worldwide distribution: USA including states of: CA, FL, LA, MI, MT, NE, NH, OH, PA, SD, TN, TX, VT, and WA; and countries including: Sweden and Australia.
Product codes and lots: Part Number 5190013140, Lot 9188017

Product code HBE

K032303Class IIStryker Consolidated Operating Room Equipment (Core) SystemStryker Instruments / cleared 2004-01-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)